University:
West Coast University
Course:
PHAR 837 | IPC Infectious Diseases I
Academic year:

2024
Views:

139

Pages:

67
Author:

Asal A.

Osteoporosis Ani Avoundjian, PharmD, BCPS Assistant Clinical Professor, Pharmacy Practice West Coast University Definition  Bone disorder characterized by:  Low bone mineral density (BMD)  Impaired bone architecture  Compromised bone strength y't  Predisposes a person to increased fracture risk Ed Definition this it'sgood so Increase BMD Decrease fracture risk Decrease BMD Increase fracture risk Badthis w Osteoblast to Build Osteoclast or resorption Pathogenesis Healthy young adults: bone turnover cycle is balanced W Bone remodeling acceleration due to risk factors (chronic disease, aging, mechanical, hormonal, biochemical exposures) ow Trabecular bone depleted more rapidly than cortical Bone loss typically seen in spine first Eon Types of Fractures Y 3 Motor dng eestipendvertebralfraction good Types of Fractures Em  Hip***  8-36% increased risk of mortality  60% do not fully regain pre-fracture independence  Vertebral  Kyphosis  Pain, disability, deformity, premature death  Wrist  Less disabling than hip and vertebral fractures  Strongly predictive of future fractures Diagnosis S e_7  Gold standard: DEXA or DXA scan  Measures BMD of spine and hip and calculates a T-score or a Z-score  If DXA scan unavailable, may do ultrasound Diagnosis  Who should have BMD measured?  Women over 65 years of age postraapusal  Men over 70 years of age  Younger patients at high risk of fractures  History of fragility fracture after age 50  Risk for disease or drug-induced bone loss  Parental history of hip fracture  Other clinical risk factors (e.g. smoking, alcoholism, low body weight) Diagnosis  BMD  Can measure progression/response to therapy  T-score knowthe difference  Diagnosis  Comparison to healthy, young, sex-matched white population  Z-score  Comparison to healthy, age-matched and sex-matched population en t 25 3 N BM EXIM 28tÉB 2 y rosi ostop osteopena g T-score interpretation Focus on T-score spinLumbar (L1-L4) Hip (proximal femur, femoral neck, total femur) t Use lowest T-score to classify and diagnose Normal vs osteopenia vs osteoporosis which ear is leaststore Patient Case  74 year old Caucasian female patient s  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily ft standard  DXA Results:  L1-L4: T-score = 0.5 tip f  Femoral Neck: T-score = -2.3 30th Eggs  Proximal Femur: T-score = -2.4  How would you classify this patient? Osteopenia Question Thehigher tore thebetter Which has the highest bone mineral density (BMD)? Best a)T-score = -3.5 b)T-score = -2.0 c) T-score = 0 d)T-score = +1.5 Eon Risk Factors  Unchangeable/ not modifiable  Gender  Age Asian hispanic non cocation p Race Female 6 mofo  Family history  Body frame size  Hormone levels  Sex hormone  Thyroid • Dietary factors • Low calcium intake • Eating disorder • GI surgery • Lifestyle 6358 • Sedentary lifestyle • Excessive alcohol consumption • Tobacco use  Long term medication  Corticosteroids  Cancer Rx  Transplant rejection Slide from G. Sabnis Medications that Increase Osteoporosis Risk  Glucocorticoids (CPR II)  Anticoagulants (CPR III)  Anticonvulsants (Neuro)  Aromatase inhibitors (Oncology)  GnRH antagonists (Endo/Oncology)  Chemotherapy (Oncology) women Patient Case men Zakonodrinksday z alcoholdrinks day  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory t703 BMI  Height: 64” Weight: 110 lbswe ing  What are her risk factors for osteoporosis? pyx703 188 Eton Fracture Risk  Contributors:  Age  Gender  BMI  Personal hx of fracture  Family hx of fracture  Current smoking  EtOH 3+ drinks daily  Rheumatoid arthritis  Glucocorticoids  Secondary osteoporosis  Femoral neck BMD Hip Fracture Risk Assessment Tool (FRAX)  Developed by World Health Organization Egm at  Estimates risk of osteoporotic fracture in next 10 years  For postmenopausal women and men >50 years of age  https://frax.shef.ac.uk/FRAX/tool.aspx?country=9 Patient Case BMD Define byT score Masovostprsis  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily,Anextboyrta Centrum Silver MVI PO daily o stop  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory  Height: 64” Weight: 110 lbs  T scores: -2.6 lumbar spine, - 2.6 hip  Calculate the patient’s FRAX score Prevention  Weight-bearing exercise (walking, jogging, Tai-Chi)  Muscle-strengthening exercise (weight training, yoga)  Smoking cessation, reducing alcohol intake, adopting fall prevention strategies  Fall prevention for low BMD  Home safety assessment (proper lighting, floors are safe, bathrooms with safety bars)  Adequate corrective lenses  Safe shoes and appropriate clothing  Cane or walkers should be strongly recommended Eton Supplements it psepoate Group Women Men 50 - 70 Men 71 and older Calcium (mg) 1200 1000 1200 at Vitamin D (IU) 800 - 1000 i 800 - 1000 800 - 1000 food carp *Remember: difference between calcium carbonate vs. calcium citrate* 2 elemental Gyorgyfood 4401 Patient Case  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory  Height: 64” Weight: 110 lbs  T scores: -2.6 lumbar spine, - 2.6 hip  How much calcium and vitamin D supplementation does she need? 1200mg a Us800 ooome When to Start Treatment Em  Postmenopausal women or men older than 50 yo presenting with (any of the 3 below):  Vertebral or hip fracture osteoporosis  T-score of −2.5 or less at the hip or spine  Osteopenia and a 10-yr probability (use FRAX)  Hip fracture >/= 3% OR major osteoporosis-related fracture >/= 20% I Goals of Drug Therapy  Prevent additional bone loss  Increase bone mass  Reduce risk of fractures Patient Case  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily  DXA Results:  L1-L4: T-score = -0.5  Femoral Neck: T-score = -2.6 ostopresis  FRAX Score: moretteenz  10-yr hip fracture probability: 4.9%  10-yr major osteoporosis fracture probability: 14% Is she a candidate for pharmacologic therapy? yes Pharmacological Therapies mosttimefiBIire Bisphosphonates Alendronate (Fosamax®) Risedronate (Actonel®) Ibandronate (Boniva®) Zoledronic acid (Reclast ®) Exam Pharmacological Therapies Eon Raloxifene (Evista®) Estrogen** Conjugated estrogens/bazedoxifene (Duavee®)*** Denosumab (Prolia®) Teriparatide (Forteo®) Abaloparatide (Tymlos®) Romosozumab (Evenity®) Calcitonin (Miacalcin®) Ethel Bisphosphonate Dosing iferased fit ago Renal Dose Generic Brand Dosage Forms Dose Alendronate Fosamax Oral Tx: 10 mg orally daily or 70 mg orally weekly Px: 5 mg orally daily or 35 mg orally weekly Ibandronate Boniva Oral, IV Tx: 150 mg orally monthly, 3 Caution if CrCL mg IV quarterly <30 mL/min Px: 150 mg orally monthly Vertebral Risedronate Actonel Oral Tx and Px: 5 mg orally daily, Caution if CrCL 35 mg orally weekly, 150 <30 mL/min mg orally monthly Both Zoledronic acid Reclast IV Tx: 5 mg IV infusion yearly Px: 5 mg IV infusion every 2 years Adjustment Caution if CrCL <35 mL/min Reduction in hip or vertebral fractures Both Contraindicated Both if CrCL <35 g mL/min provider's office Question What dose of alendronate do you recommend to prevent progression to osteoporosis (select all that apply)? a)150 mg orally monthly b)5 mg IV infusion yearly c) 5 mg orally daily d)35 mg orally weekly Question Which bisphosphonate does NOT have proven data to reduce hip fractures? a)Ibandronate b)Risedronate c) Alendronate d)Zoledronic acid Bisphosphonates - Pharmacokinetics A Breakdown SIP  Anti-resorptive agents  Bioavailability <1%  Food reduces by another 50%  Incorporates into bone  Long biologic half-lives (up to 10 years)  Binding strength to bone:  Zoledronic acid > alendronate > ibandronate > risedronate Exam Take with 4-8 oz of plain water at least 30 min before first food , beverage or medication of day. Do not lie down for at least 30 min and until after first food Adverse Effects no GI Effects: Zoledronic acid: • Dyspepsia • Heartburn • N/V • Esophagitis • Rare: ulceration/bleeding • Edema • Hypotension • Dehydration • Injection reaction • Muscle pain Rare, Serious Adverse Effects Hip o  Atypical femoral as shaft fractures  Risk can increase with longer duration bisphosphonate use 2  Osteonecrosis of jaw (ONJ)  More common in patients with cancer receiving higher dose IVbisphosphonate therapy  Osteonecrosis incidence: 0.001% to 0.01%  Dental-specific risk factors  Poor dental hygiene  Maxillary/mandibular surgery  Try to have major dental work before therapy Bisphosphonate Drug Holiday  Used to mitigate risk of adverse effects  Consider after:  5 years of treatment – oral I  3 years of treatment – IV  Should be monitored during holiday and restarted on therapy if fracture occur or significant BMD losses  Optimal duration of holiday unknown Bisphosphonate Contraindications  Hypocalcemia  Resolve prior to therapy 2 Inability to stand or sit upright for at least 30 minutes  3  Abnormalities of the esophagus u  High risk of aspiration ima Choosing a Bisphosphonate NOIchoose bardonataetBada I  Evidence to reduce hip fractures  Formulation  Frequency  Administration  Cost  Alendronate < Ibandronate < Risedronate < Zoledronic Acid estrogenicat utursand Agonistattaboy Anti Eres Selective Estrogen Receptor Modulator (SERM) bong dosithavedoggybreastcancerrisk help  Raloxifene (Evista) precut Anti-resorptive agent beatdown ~30% reduction in vertebral fractures SLID Selective Estrogen Receptor Modulator (SERM) reduce riskofbreastcancer in Help no wholove  Raloxifene (Evista) ostopsis  Dose: 60 mg oral daily  BBW: increased risk of VTE; increased risk of death due to stroke in women with CHD or at risk for coronary events  Contraindications: VTE, pregnancy Oh 8th  Discontinue 72 hours prior to and during prolonged immobilization paininjoint  ADRs: hot flashes, peripheral edema, arthralgia, leg cramps Selective Estrogen Receptor Modulator (SERM) Raloxifene (Evista) Indications: 1. Prevention and treatment of osteoporosis in postmenopausal women 2. Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis Place in therapy: Prevent vertebral fractures in postmenopausal women who have low risk of deep vein thrombosis for whom bisphosphonates or Denosumab are not appropriate or For women with a history of or high risk for breast cancer Doesn’t really help with vasomotor sxs such as hot flashes preventiononly i no Estrogen Dont pickit PIHogston  Prevents bone loss associated with post-menopausal osteoporosis  Risks: Breast cancer, endometrial hyperplasia/cancer (unopposed estrogen), MI, stroke, pulmonary emboli, VTE  Women’s health initiative (WHI)  Study stopped in 2002  Increased risk of breast cancer, heart disease, stroke, and blood clots  NOT PREFERRED Conjugated estrogens/bazedoxifene (Duavee)  Conjugated estrogens 0.45 mg  Bazedoxifene 20 mg  Once daily  Increases hip and vertebral BMD  No fracture data Same tablet Conjugated estrogens/bazedoxifene (Duavee)  Estrogen + SERM combination for osteoporosis prevention in postmenopausal women with a uterus who have moderate to severe vasomotor symptoms of menopause  BBW: Endometrial cancer (unopposed estrogen); increased risk of DVT and stroke in postmenopausal women 50-79 years of age; dementia in women >65  Contraindications: Breast cancer (any history); pregnancy, undiagnosed uterine bleeding, history of or active VTE, MI or stroke, hepatic impairment  ADRs: nausea, diarrhea, dyspepsia, abdominal pain, muscle spasms  Use estrogen-containing products for the shortest duration possible Receptor Activator of Nuclear Factor kappa-B Ligand (RANKL) Inhibitor  Denosumab (Prolia) so  Monoclonal antibody  Anti-resorptive agent  Decreases hip and vertebral fractures  Subcutaneous injection  Given in office by healthcare professional Receptor Activator of Nuclear Factor kappa-B Ligand (RANKL) Inhibitor  Denosumab (Prolia)  Dose: 60 mg SC every 6 months  Contraindications: Hypocalcemia; pregnancy  Warnings: Osteonecrosis of jaw, atypical femur fractures, hypocalcemia, infections  ADRs: back pain, pain in extremities, hypercholesterolemia, cystitis (women), nasopharyngitis (men)  If discontinued, bone loss can be rapid; consider alternative agents to maintain BMD Parathyroid Hormone 1-34  Analogs of human parathyroid hormone  Teriparatide (Forteo)  Abaloparatide (Tymlos)  Stimulate osteoblast activity and increase bone formation  Anabolic agents  Cumulative lifetime treatment duration restricted to two years or less due to osteosarcoma BBW Forger  Keep refrigerated Parathyroid Hormone 1-34 Bonecancer so  BBW: Osteosarcoma (risk dependent on dose and duration of use)  Warnings: Hypercalcemia; orthostatic hypotension t  ADRs: Arthralgias, leg cramps, nausea, orthostasis/dizziness  Abaloparitide: increased uric acid Generic Brand Dosage Forms Dose Reduction in hip or vertebral fractures Teriparatide Forteo SC Tx: 20 mcg daily Vertebral Abaloparatide Tymlos SC Tx: 80 mcg daily Vertebral 8 Romosozumab (Evenity)  Indication: postmenopausal women with osteoporosis at high risk for fracture  Monoclonal antibody that binds and inhibits sclerostin  Anabolic and anti-resorptive agent  Increases activity of osteoblasts  Decreases activity of osteoclasts Romosozumab (Evenity)  210 mg subcutaneously  Supplied as 105 mg/1.17 mL single-use prefilled syringe  Two syringes per dose  Administered by HCP  Refrigerate until use Romosozumab (Evenity) spin  Decreases vertebral fractures  BBW: Increased risk of MI, stroke and cardiovascular death  Contraindications: Hypocalcemia, known hypersensitivity to Evenity  Warnings and Precautions: MACE, ONJ, , atypical femur fracture  ADRs: Arthralgia, headache, injection site reactions  Keep refrigerated eventlyfirst thenfollowed byprong to showsbenefit 0 not pickles Calcitonin (Miacalcin)  Decreases vertebral fractures alone with no fracture reduction demonstrated with higher and lower doses  Less effective than other agents Calcitonin (Miacalcin)  Dose: 200 units in one nostril daily  Warnings: Hypocalcemia, Increased risk of malignancy with longterm use, hypersensitivity to salmon-derived products  ADRs: rhinitis, nasal irritation, occasional epistaxis, myalgia, nausea, dizziness  Keep refrigerated Selecting a Therapy  Remember the primary goal  Prevent fractures! *HIP* O  Other considerations  Medication concerns  Comorbidities  Administration  Cost/third party coverage Selecting a therapy  Risk assessment:  High risk: Prior spine or hip fracture; or a lumbar spine or hip Tscore of − 2.5 or below; and/or a FRAX 10-year absolute fracture risk above treatment threshold  Bisphosphonates (except ibandronate)  Alt: denosumab PII Dositcoverhip  Very high risk: Multiple spine fractures/hip fracture and T score of − 2.5 or lower at lumbar spine or hip. a  Anabolic agents (Teriparatide, abaloparatide, romosuzumab) -> antiresorptive agents ORDER MATTERS!!!  Alt: denosumab or bisphosphonates (except ibandronate) Type of Fracture Risk Reduction Kate fraction Hip Agent Vertebral Hip Alendronate (Fosamax) X X Risedronate (Actonel) X X Ibandronate (Boniva) X Zoledronic Acid (Reclast) X X Estrogen X X Raloxifene (Evista) X Calcitonin (Miacalcin) X Teriparatide(Forteo) X Abaloparatide (Tymlos) X Denosumab (Prolia) X Romosuzumab (Evenity) X X Eton Boxed Warnings Agent Boxed Warning Alendronate (Fosamax) Risedronate (Actonel) Ibandronate (Boniva) Zoledronic Acid (Reclast) Denosumab (Prolia) Calcitonin (Miacalcin) Estrogen X Raloxifene (Evista) X Teriparatide(Forteo) X Abaloparatide (Tymlos) X Romosuzumab (Evenity) X Conjugated estrogens/bazedoxifene (Duavee) X Oral vs IV Agent Oral Alendronate (Fosamax) X Risedronate (Actonel) X Ibandronate (Boniva) X Conjugated estrogens/bazedoxifene X Estrogen X (also TD) Raloxifene (Evista) X Injectable X Zoledronic Acid (Reclast) X Denosumab (Prolia) X Teriparatide(Forteo) X Abaloparatide (Tymlos) X Romosuzumab (Evenity) X Anti-Resorptive vs Anabolic Agent Anti-Resorptive Alendronate (Fosamax) X Risedronate (Actonel) X Ibandronate (Boniva) X Zoledronic Acid (Reclast) X Raloxifene (Evista) X Denosumab (Prolia) X Anabolic Teriparatide(Forteo) X Abaloparatide (Tymlos) X Romosuzumab (Evenity) X X Osteoporosis Therapies Daily Weekly Monthly Less often Annual Alendronate Alendronate Risedronate Ibandronate 3 months Zoledronic acid Risedronate Risedronate Ibandronate Denosumab 6 months Conjugated estrogen/ bazedoxifene Estrogen Raloxifene Abaloparatide Teriparatide Calcitonin Romosuzumab Drugs and Calcium Agent Increase Decrease Alendronate (Fosamax) X Risedronate (Actonel) X Ibandronate (Boniva) X Zoledronic Acid (Reclast) X Calcitonin (Miacalcin) X Teriparatide(Forteo) X Abaloparatide (Tymlos) X Denosumab (Prolia) X Romosuzumab (Evenity) X Patient Case  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory  Height: 64” Weight: 110 lbs ostoprosis  T scores: -2.6 lumbar spine, - 2.6 hip  What osteoporosis therapy should be initiated? Bisphosphate except bodied Patient Case  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory  Height: 64” Weight: 110 lbs  T scores: -2.6 lumbar spine, - 2.6 hip  What medication counseling is important? Patient Case  74 year old Caucasian female patient  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory  Height: 64” Weight: 110 lbs  T scores: -2.6 lumbar spine, - 2.6 hip  What lifestyle counseling is important? Patient Case  74 year old Caucasian female patient – 5 years later  PMH: HTN  Current medications: amlodipine 5 mg PO daily, Centrum Silver MVI PO daily, alendronate 70 mg weekly  SH: 2 cups of coffee daily, 1 – 2 glasses of wine three times per week, little exercise  FH: non-contributory  Height: 64” Weight: 110 lbs  T scores: -2.6 lumbar spine, - 2.6 hip  What serious AE may be impacted by her osteoporosis therapy duration? Patient Case Rod  51 year old Caucasian female complains of significant hot flashes. She also worries about breaking a hip.  PMH: not significant  Current medications: Calcium and vitamin D Dog  SH: regular exercise, non-smoker, 1 – 2 alcoholic beverages on weekends  FH: mother had hip fracture  What medication(s) would be a good recommendation? Patient Case  72 year old Caucasian female patient  PMH: hip fracture 1 month ago  Current medications: alendronate 70 mg weekly x 2 years; analgesic for hip fracture pain, adequate Ca + D  SH: denies EtOH, smoking; golfs three times a week (prior to fx)  FH: mother with kyphosis  Height: 66” Weight: 135 lbs  T scores: -2.9 lumbar spine, - 3.4 hip ostoprosis  How should we adjust her osteoporosis therapy? Highrise up du no swab police

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